Evaluation of the Novel Silq ClearTract Catheter in Patients With Chronic Urinary Retention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-26

Study Completion Date

2025-07-26

Brief Summary

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To assess the ability of the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter to reduce catheter associated complications in subjects that require a long-term indwelling Foley catheter when compared to other commercially available Foley catheters.

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Detailed Description

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A prospective, randomized, multi-center, post-market study in subjects that require a long-term indwelling Foley catheter.

Neurogenic bladder is commonly managed with indwelling catheters (urethral or suprapubic). Indwelling catheters are associated with multiple complications, including recurrent urinary tract infections and catheter obstruction. A randomly assigned catheter will be inserted using standard techniques. The assigned catheters will either be the SILQ ClearTract 100% Silicone 2-Way Foley Catheter or the current standard of care catheter. Subjects will continue to use the assigned catheter for a period of approximately 3 months following regular standard of care. Subjects will then be assigned the alternative catheter for an additional 3 month period after which they will be exited from the study

The purpose of the study is to compare the incidence of catheter-related complications between the SILQ treated catheter and the current standard of care catheter(s). Because these complications lead to more frequent interventions and associated treatment costs, the study will also calculate the economic impact of the use of SILQ treated catheters compared to standard of care catheters. Patient-reported outcomes will also be measured via questionnaires upon each study visit. Explanted catheter samples will also be sent to a core lab for quantification of the calcification present on the catheter surface.

Conditions

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Catheter Infection Catheter Blockage Catheter Related Complication Catheter Calcification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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SILQ ClearTract 100% Silicone 2-Way Foley Catheter

Subjects in this arm will receive the SILQ ClearTract 100% Silicone 2-Way Foley Catheter for approximately the first 3 month period of enrollment. In a subsequent period of approximately 3 months subjects in this arm will receive their current standard of care catheter.

Group Type ACTIVE_COMPARATOR

SILQ ClearTract 100% Silicone 2-Way Foley Catheter

Intervention Type DEVICE

A foley catheter is assigned and used according to regular standard of care

Standard of Care Catheter

Subjects in this arm will receive their current Standard of Care Catheter for the first 3 month period of enrollment. In a subsequent period of approximately 3 months subjects in this arm will receive the SILQ ClearTract 100% Silicone 2-Way Foley Catheter

Group Type ACTIVE_COMPARATOR

SILQ ClearTract 100% Silicone 2-Way Foley Catheter

Intervention Type DEVICE

A foley catheter is assigned and used according to regular standard of care

Interventions

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SILQ ClearTract 100% Silicone 2-Way Foley Catheter

A foley catheter is assigned and used according to regular standard of care

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* At least 18 years old
* Requirement of a 14 Fr, 16Fr, or 18Fr indwelling urethral or suprapubic urinary catheter (for at least 6 months) for bladder drainage.
* Able and willing to comply with study procedures
* Able and willing to give informed consent.

Exclusion Criteria

* History of reconstructive bladder surgery such as bladder augmentation or continent catheterizable stoma.
* Cognitive deficit limiting the ability to respond to clinical questionnaires.
* Allergy or sensitivity to any catheter material used in this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes